EU Clinical Trials Regulation (CTR 536/2014)
What is EU Clinical Trials Regulation (CTR 536/2014)?
Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) harmonises the authorisation and conduct of clinical trials on medicinal products for human use across the EU/EEA. It repealed Directive 2001/20/EC and came into application on 31 January 2022 following the go-live of the Clinical Trials Information System (CTIS), with mandatory CTIS use from 31 January 2023 (new trials) and full transition by 31 January 2025 (legacy 2001/20/EC trials). It comprises 30 controls organised across 8 domains, and applies in the European Union.
How EU Clinical Trials Regulation (CTR 536/2014) maps to other frameworks
All 30 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 8 domains EU Clinical Trials Regulation (CTR 536/2014) groups its controls into
Where EU Clinical Trials Regulation (CTR 536/2014) overlaps with the standards you already hold
What EU Clinical Trials Regulation (CTR 536/2014) means in your sector
What EU Clinical Trials Regulation (CTR 536/2014) means for your job
Questions people ask about EU Clinical Trials Regulation (CTR 536/2014)
What is EU Clinical Trials Regulation?
How many controls does EU Clinical Trials Regulation have?
Where does EU Clinical Trials Regulation apply?
What frameworks does EU Clinical Trials Regulation map to?
How do I get started with EU Clinical Trials Regulation compliance?
Query EU Clinical Trials Regulation (CTR 536/2014) programmatically
EU Clinical Trials Regulation (CTR 536/2014), its 30 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
EU Clinical Trials Regulation (CTR 536/2014) API reference and MCP config →What EU Clinical Trials Regulation (CTR 536/2014) requires, control by control
Each page carries the requirement text for one EU Clinical Trials Regulation (CTR 536/2014) control and what an assessor expects to see as evidence.
How ready are you for EU Clinical Trials Regulation (CTR 536/2014)?
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